BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A&H SPINBRUSH PRO CLEAN REPLACEMENT HEAD SOFT 2 CT

    MDR report key: 9963387 · Received April 15, 2020

    Report

    Report Number
    2280705-2020-00012
    Event Type
    Malfunction
    Date Received
    April 15, 2020
    Date of Event
    April 4, 2020
    Report Date
    September 25, 2020
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT AND THE INFORMATION SUBMITTED UNDER THIS REPORT DO NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR CHURCH & DWIGHT CO., INC. OR ANY OF ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED HEREIN OR THAT THE EVENT AS REPORTED TO CHURCH & DWIGHT ACTUALLY OCCURRED.

    Additional Manufacturer Narrative · 0

    THIS REPORT AND THE INFORMATION SUBMITTED UNDER THIS REPORT DO NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR CHURCH & DWIGHT CO., INC. OR ANY OF ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED HEREIN OR THAT THE EVENT AS REPORTED TO CHURCH & DWIGHT ACTUALLY OCCURRED. FOLLOW-UP #2 BEING SUBMITTED WITH THE COMPLETED INFORMATION IN SECTION D9 AS THE FORM WAS NOT ALLOWING ME TO MAKE A SELECTION IN THAT SECTION IN FOLLOW-UP #1.

    Description of Event or Problem · 0

    PRODUCT RECEIVED AND EVALUATED. THE EVALUATION DOES NOT CHANGE INITIAL REPORTABILITY REQUIREMENTS.

    Description of Event or Problem · 0

    PRODUCT RECEIVED AND EVALUATED. THE EVALUATION DOES NOT CHANGE INITIAL REPORTABILITY REQUIREMENTS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PRODUCT COMPONENTS ARE MANUFACTURED AT THE FOLLOWING CONTRACT MANUFACTURING LOCATIONS. SINCE THE CONSUMER HAS NOT RETURNED THE PRODUCT TO DATE, WE ARE UNABLE TO DETERMINE WHICH EXACT PRODUCT WAS USED AND AT WHICH LOCATION THE PARTICULAR PRODUCT WAS MANUFACTURED. HEADS ARE MANUFACTURED AT THE FOLLOWING LOCATION: (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THAT HE'S HAD SEVERAL MORE SPINBRUSH REPLACEMENT HEADS BREAK AND SHATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429579 A&H SPINBRUSH PRO CLEAN REPLACEMENT HEAD SOFT 2 CT POWERED TOOTHBRUSH JEQ CHURCH & DWIGHT CO., INC. 6687800080 TE9283, DD9151, DD9152

    Patients

    Seq Age Sex Outcome Treatment
    1